The efficacy and safety of Eftilagimod Alpha Treatment in COVID-19 disease (EAT COVID trial)

The efficacy and safety of Eftilagimod Alpha Treatment by immune modulation in COVID-19 disease (EAT COVID trial) - EAT COVID trial

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002009-25-CZ

Enrollment

104

Registered

2020-06-04

Start date

2020-10-01

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 disease MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: Eftilagimod Alpha Product Code: IMP321 Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults (>18yrs of age) with confirmed COVID-19 disease who require hospital admission 2. Need for less than 8L/min of O2 via supplemental device to maintain SpO2 > 92% 3. Signed informed consent by patient Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 32 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 72

Exclusion criteria

Exclusion criteria: 1. Patients who require > 8L O2/min via a supplemental device to maintain SpO2>92% 2. Patients who are in shock as defined by vasopressor requirements 3. Patients with clear limitations of treatment (not for intubation) 4. Moribund patients 5. Pregnant patients 6. Known allergy to Eftilagimod Alpha, or L-Arginine

Design outcomes

Primary

Measure	Time frame
Main Objective: We aim to assess the effects of Eftilagimod alpha (Efti) on the number of days alive without life-support in adult patients hospitalised with COVID-19. Eftilagimod Alpha leads to enhanced presentation of viral antigens to T-cells resulting in an effective, sustained antiviral response and viral clearance.;Secondary Objective: To evaluate the effects of Efti on indicators of inflammation, need for oxygen therapy, mechanical ventilation, length of hospitalisation and mortality.;Primary end point(s): patient’s clinical status (on a 7-point ordinal scale) at day 15 as per an adapted WHO recommended study protocol. 1. Not hospitalized, 2. Hospitalized, not requiring supplemental oxygen 3. Hospitalized, requiring supplemental oxygen 4. Hospitalized, on high flow oxygen device 5. Hospitalized in ICU, on non-invasive ventilation 6. Hospitalized in ICU, on invasive mechanical ventilation or ECMO 7. Death;Timepoint(s) of evaluation of this end point: Day 15 post study entry	—

Measure

Time frame

Main Objective: We aim to assess the effects of Eftilagimod alpha (Efti) on the number of days alive without life-support in adult patients hospitalised with COVID-19. Eftilagimod Alpha leads to enhanced presentation of viral antigens to T-cells resulting in an effective, sustained antiviral response and viral clearance.;Secondary Objective: To evaluate the effects of Efti on indicators of inflammation, need for oxygen therapy, mechanical ventilation, length of hospitalisation and mortality.;Primary end point(s): patient’s clinical status (on a 7-point ordinal scale) at day 15 as per an adapted WHO recommended study protocol. 1. Not hospitalized, 2. Hospitalized, not requiring supplemental oxygen 3. Hospitalized, requiring supplemental oxygen 4. Hospitalized, on high flow oxygen device 5. Hospitalized in ICU, on non-invasive ventilation 6. Hospitalized in ICU, on invasive mechanical ventilation or ECMO 7. Death;Timepoint(s) of evaluation of this end point: Day 15 post study entry

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Secondary

Measure	Time frame
Secondary end point(s): 1. Supplemental oxygen free days in the first 28 days (up to day 29) 2. Ventilator free days in the first 28 days (up to day 29) 3. Subject clinical status (on a 7-point ordinal scale as above) at day 7 and day 21, respectively 4. ICU LOS 5. Hospital LOS 6. Mortality at 28 and 90 days ;Timepoint(s) of evaluation of this end point: Day 7, 21, 28, and 90 post study entry	—

Countries

Czech Republic

Contacts

Public ContactProf Martin Matejovic

Fakultni nemocnice

matejovic@fnplzen.cz+420377103111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026